Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico (PROSPECT)
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ClinicalTrials.gov Identifier: NCT03794531
Recruitment Status :
Enrolling by invitation
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Harvard School of Public Health
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Minority Health and Health Disparities (NIMHD)
The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,000 adults (30-75 years) in PR recruited with a multi-frame sampling of probabilistic plus community approaches, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.
Number of participants with self-reported medically-diagnosed chronic diseases [ Time Frame: 4 years ]
Estimate the prevalence and incidence of chronic diseases (and their dietary and psychosocial risk factors)
Secondary Outcome Measures :
Difference in the number of participants with self-reported medically-diagnosed chronic diseases living urban vs. rural area [ Time Frame: 4 years ]
Estimate differences in prevalence and changes in chronic diseases (and their dietary and psychosocial risk factors) in urban vs. rural area
Other Outcome Measures:
Risk of clinically-measured metabolic syndrome (e.g. high blood pressure, elevated adiposity, elevated blood glucose, and out-of-normal-range blood lipids), according to dietary and psychosocial risk factors [ Time Frame: 4 years ]
Determine risk of biological metabolic risk factors by changes in psychosocial factors or diet-related factors
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Ages Eligible for Study:
30 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Representative sample of eligible adults living in all of Puerto Rico.
Age 30-75 years old at the time of enrollment
Living in PR at the time of the first interview and the year before and not planning to move from the island within 3 years
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
IPD will be managed and distributed observing NIH and IRB policies on the dissemination and sharing of research results. Study information and requests for data will be available immediately upon the data being de-identified and properly revised for quality control on the study website.
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
The requested data will be shared with investigators via a secured, password-protected software website.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Josiemer Mattei, Harvard School of Public Health:
Chronic disease risk factors
Caribbean and Latin America